Metastatic Castrate- Resistant Prostate Cancer Clinical Trial
Official title:
Phase I Study of Idronoxil Combined With Radiation Treatment in Men With Metastatic Prostate Cancer
Verified date | May 2022 |
Source | Royal North Shore Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study is to determine the toxicity of Idronoxil (NOX66) when used in combination with palliative radiotherapy for metastatic prostate cancer
Status | Terminated |
Enrollment | 1 |
Est. completion date | September 17, 2019 |
Est. primary completion date | September 17, 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Confirmed metastatic prostate cancer that is castrate-resistant. - 2-3 lesions suitable for radiotherapy. - ECOG Performance status 0-2. - Adequate bone marrow, hepatic and renal function - At least 4 weeks must have elapsed prior to commencement of idronoxil treatment since prior chemotherapy, investigational drug or biologic therapy Exclusion Criteria: - Chemotherapy regimens with delayed toxicity within the last 4 weeks. - Any situation where the use of suppository therapy is contra-indicated or impractical(eg. chronic diarrhoea, colostomy, ulcerative colitis). - No concurrent systemic chemotherapy or biologic therapy is allowed. - Psychiatric disorder or social or geographic situation that would preclude study participation. - Patient unable to provide consent |
Country | Name | City | State |
---|---|---|---|
Australia | Royal North Shore Hospital | St Leonards | New South Wales |
Lead Sponsor | Collaborator |
---|---|
Royal North Shore Hospital |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | safety of Idronoxil dose escalation | Toxicity and relationship with study drug NOX66 will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V4.3 | From start of NOX66 with stereotactic radiotherapy up to three months post treatment. | |
Secondary | evidence of clinical tumour response | PSMA-PET CT will be done before and 3 months after treatment. The change in SUV in PSMA PET will be used to assess tumour metabolic response. Pre and post treatment tumour size on CT will be measured and RECIST criteria will be used to measure tumour response. |
3 months post treatment |